Socialist Viewpoint

The Food and Drug Administration, (F.D.A.) is the government agency responsible for the safety of products available on the market, including foods and drugs, and in the regulation of devices such as ultrasound equipment, etc. For instance, in the field of medicine and the health industry, when a company develops a new product to treat or diagnose some medical condition, they must patent it. Granting of that patent guarantees the manufacturer a monopoly in production and sale of the product for twenty years. It is also supposed to insure the safety of that product for the public. But while the F.D.A. lists these patents and safeguards each company’s monopoly—their track record is notorious when it comes to public safety. (How many drugs can you count off the top of your head that have been recalled because of sometimes-fatal health risks?)

The idea behind the twenty-year monopoly is to allow for the manufacturer to make up for the cost of research and development of the product and to encourage such development for the common good. After the twenty years are up, the companies have been compensated, the patent is expired, and the formula is in the public domain. Competing companies can then manufacture a “generic” version of the drug at a far lower cost to the consumer—the same way that aspirin is manufactured by a multitude of different companies.

However, if the same company can make certain improvements or changes to a product they can ask for extensions on their patent and maintain their monopoly. But, according to a New York Times editorial dated October 22, 2002 entitled, “Ending a Drug Patent Scam,” the F.D.A. has overlooked many loopholes that allow manufacturers to extend their patents for frivolous reasons such as changing the color or shape of the container.

The editorial points out further that, “Some brand-name manufacturers have been extending the effective lives of their patents by tactics that are underhanded at best and appear fraudulent at worst…but through loopholes in current law, the companies can get an automatic 30-month extension simply by filing suit against a generic manufacturer…”

In another New York Times, article dated September 24, 2002, entitled “Some Retirees Look Abroad for Prescription Drugs,” author Randi Hutter Epstein interviewed five retirees who could not afford to buy their prescription drugs in the United States because of the high costs of medication here and have traveled to Mexico or Canada for lower prices.

“As an example,” Epstein reports, “a retired steel company welder and foreman, Mr. Sanchez, of San Antonio, is enrolled in an H.M.O., paid for by Medicare. He pays $10 to $30 a month for each prescription. He is taking four drugs and his wife, Yolanda, is taking seven.

“It’s hard, it’s real hard. My wife is on medicine for her thyroid, and she also takes medicine for her diabetes, high blood pressure, and asthma. It’s tight, especially when you think we have to pay for groceries and utilities. I am on medicine for back and shoulder pain and medicine to lower my cholesterol.

“Sometimes we just don’t buy the drugs because they are too expensive. We try not to go longer than a week off medicine. At one point her sugar got really high. What we do is we wait and get free samples from the doctor…”

The article points out that there’s even a growing industry in senior drug-buying tours where busloads of senior citizens travel together to get the cheapest prices. Their stories illustrate how these loopholes have impacted sick people. Instead of protecting the interests of those who need the medication by making sure there is a legitimate reason to give an extension to a patent, the F.D.A. has been extending them practically on demand.

The consistent track record of the F.D.A. to act against the public interest in favor of corporate greed is typical of capitalist governmental agencies that are supposed to be our public watchdogs. This fact is further revealed in a story dated October 22, 2002 on CNN about doctor’s fears that frequent ultrasounds might be unsafe. Debra Goldschmidt of CNN’s Medical Unit describes the birth of a new franchise, Fetal Fotos in Salt Lake City, Utah.

Not yet approved by the F.D.A., this franchise is one of thousands of such businesses operating in malls across the country according to The American Institute of Ultrasound in Medicine. Women can come in with friends and family and for $60 to $120, depending on image resolution and store location, and get an ultrasound image of their child before it’s born.

It sounds harmless enough but, according to the article, there is a problem, “Doctors…said they are concerned that too many ultrasounds may be unsafe. There is no documented danger, but this same technology is used to heat tissue for therapy and—at high frequencies—to break apart kidney stones and gallstones. Doctors said they also worry that frequent ultrasounds will give an expectant mother and her family a false sense of security.”

The ramifications of this were expressed by Dr. Joshua Copel, an obstetrician at Yale University in New Haven, Connecticut who was quoted in the article as saying, “The problems that the ultrasound present are that the family is not getting any helpful information for managing the pregnancy…Nobody is providing oversight to the sonographer to evaluate the fetal anatomy and make sure the baby is developing normally.” So, for a women who has no pre-natal care or health insurance, seeing what seems to be a normal fetus for $60, could falsely reassure her that everything is all right. However, there very well could be a medical problem that a pre-natal doctor could spot on the ultrasound image.

The F.D.A., in an attempt to cover its complicity, has officially not approved this excessive use of ultrasound and has recommended to women that they have only one ultrasound per pregnancy when prescribed by a doctor—which is the norm in pre-natal care for the typical low-risk pregnancy. But they have not shut down these commercial ultrasound photo studios. Instead they claim to have “evaluated” these businesses to make sure they follow “certain guidelines.”

But letting them stay in operation sends out a mixed message to pregnant women and gives them a false sense of the safety of this practice. And, in fact, the F.D.A.’s claim of “evaluating” these businesses reinforces a false confidence that they are safe and being monitored, which they are not.

It is obvious that in the case of extending patents for brand name drugs the F.D.A.’s standard policy is leniency toward the manufacturer at the expense of the consumer. It has routinely granted many extensions guaranteeing huge profits for the companies involved even when the cost of the life-saving medication to the poorest consumers remains prohibitive.

In the case of the ultrasound fetal photo business the F.D.A. is allowing a grand experiment to take place with no regard for the safety of mothers and their unborn babies. Even though repeated ultrasound photos could harm the mother and her fetus, the profits of a multi-million dollar business, potentially harmful to the patient, takes precedence.